(262 days)
The Storz D7120 Phaco Handpiece Maintenance Kit and the Storz D7125 Needle Wrench are intended to be used as accessories to Storz DAISY® (K854508). Storz Protegé® (K921758 and K950114). and PREMIERE® (K894278, K921460, and K946227) Microsurgical Systems for use in performing phacoemulsification. The D7120 contains an assortment of tools useful in cleaning and maintaining the Phacoemulsification Hndpiece (K935926) and the D7125 is an individual tool used in the assembly and disassembly of the handpiece.
The Storz D7120 Phaco Handpiece Maintenance Kit and the Storz D7125 Needle Wrench are intended to be used as accessories to Storz DAISY® (K854508). Storz Protegé® (K921758 and K950114). and PREMIERE® (K894278, K921460, and K946227) Microsurgical Systems for use in performing phacoemulsification. The D7120 contains an assortment of tools useful in cleaning and maintaining the Phacoemulsification Hndpiece (K935926) and the D7125 is an individual tool used in the assembly and disassembly of the handpiece.
The provided text describes a 510(k) premarket notification for ophthalmic microsurgical system accessories (Storz D7120 Phaco Handpiece Maintenance Kit and Storz D7125 Needle Wrench). This is a submission for medical devices, but it does not contain information about acceptance criteria or a study proving device performance in the context of diagnostic accuracy, a common scenario for AI/ML devices.
The document's purpose is to demonstrate substantial equivalence of these accessories to predicate devices, not to present performance data against specific acceptance criteria for diagnostic output. It's a comparison of features and intended use, not a performance study as typically understood for AI-enabled diagnostic tools.
Therefore, I cannot provide the requested information from the provided text for the following reasons:
- No Acceptance Criteria or Performance Metrics: The document does not define specific acceptance criteria (e.g., sensitivity, specificity, AUC, accuracy thresholds) that the device needs to meet. It focuses on comparing device characteristics.
- No Performance Study: There is no mention of a study designed to evaluate the diagnostic or treatment performance of the device against a ground truth. The comparison chart focuses on "Intended Use," "Tools Recommended/Included," "Instrument Type," "Tools Provided Sterile?", and "Tools Commonly Available Or Available From Supplier?".
- Device Type: The devices described are maintenance tools (handpiece maintenance kit, needle wrench), which are accessories for ophthalmic microsurgical systems. They are not AI/ML-enabled diagnostic tools that would typically undergo studies with performance metrics like those requested.
In summary, the provided text is a 510(k) summary for accessories based on substantial equivalence, not a performance study for an AI/ML device that requires acceptance criteria and an evaluation of its diagnostic or predictive capabilities.
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Image /page/0/Picture/0 description: The image shows a sequence of numbers and a letter. The sequence starts with the letter 'K', followed by the numbers '96', '00', and '24'. The text is written in a bold, sans-serif font, and the characters are closely spaced together. The overall impression is that of a serial number or code.
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Premarket Notification STORZ Instrument Company
SEP 20 1996
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
The following information is submitted in accordance with the requirements of 21 CFR 807.92:
Contact Person: Manager, Requlatory Affairs
Date Prepared: December 28, 1995
Proprietary Names: Storz D7120 Phaco Handpiece Maintenance Kit and Storz D7125 Needle Wrench.
Common/Usual Name: Ophthalmic microsurgical system accessories for phacoemulsification. .
Classification Name: System, Phacofragmentation (86 HQC).
Device Description/Intended Use: The Storz D7120 Phaco Handbiece Maintenance Kit and the Storz D7125 Needle Wrench are intended to be used as accessories to Storz DAISY® (K854508). Storz Protegé® (K921758 and K950114). and PREMIERE® (K894278, K921460, and K946227) Microsurgical Systems for use in performing phacoemulsification. The D7120 contains an assortment of tools useful in cleaning and maintaining the Phacoemulsification Hndpiece (K935926) and the D7125 is an individual tool used in the assembly and disassembly of the handpiece.
Predicate Device: The Storz D7120 and D7125 are substantially equivalent to similar cleaning and maintenance tools recommended by manuals for the Alcon Series 20000 ™ LEGACY " (K952213) and the AMO® Prestige ™ Advanced Cataract Extraction System™ (K number unknown) systems.
Predicate Comparison: A chart comparing the Storz D7120 and D7125 to the predicate devices demonstrating substantial equivalence, is attached.
Submitted by:
Milton Sattler
Michael H. Southworth Storz Instrument Company 3365 Tree Court Industrial Blvd. St. Louis, MO 63122 Ph. 314/225-5051
STORZ' 3365 Tree Court Industrial Blvd. St. I ouis. MO 63122-6694 (314) 225-5051 FAX (314) 225-7365
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DEVICE COMPARISON CHART
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| DeviceCharacteristic | AMO® Prestige™ | SERIES 20000®LEGACY™ | Storz D7120 andD7125 |
|---|---|---|---|
| Intended Use | Cleaning UltrasonicHandpieceImmediately AfterUse | Cleaning UltrasonicHandpieceImmediately AfterUse | Cleaning UltrasonicHandpieceImmediately AfterUse |
| Tools Recommended/ Included | Recommended:Syringe, FluidicsConnectors, TipWrench | Recommended:Syringe, FluidicsConnectors, TipWrench | Included: Syringe,Stopcock FluidicsConnectors, NeedleWrench, AspiratorBrush |
| Instrument Type | PhacoemulsificationHandpiece | PhacoemulsificationHandpiece | PhacoemulsificationHandpiece |
| Tools ProvidedSterile? | No | No | No |
| Tools CommonlyAvailable OrAvailable FromSupplier? | Yes | Yes | Yes |
§ 886.4670 Phacofragmentation system.
(a)
Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.(b)
Classification. Class II.